Merit Medical Q50 PLUS Instructions For Use Manual Download

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QXMédical, LLC

Page 4 of 76

Document Part Number: 3064-001, Rev. 06 (10/2019)

vessels, particularly when inflating in the distal-most area

of the stent graft, or in calcified, stenotic, and/or otherwise

diseased vessels.

•  Do not use in the heart or coronary arteries.
•  Do not use in the treatment of dissections.
•  Hand injections using a 60 cc syringe are recommended. Do

not use a pressure inflation device for balloon inflation.

• Do not use a power injector for injection of contrast medium

through distal catheter lumen. Rupture may occur.

• QXMédical is not responsible for mis-sizing, misuse or

misplacement of the device.

5. PRECAUTIONS

• Preparations should be made and a trained vascular surgical

team available in the event conversion to open surgery is

required.

• Carefully inspect the package and catheter prior to use to

verify no damage occurred during shipment. Do not use if the

package or catheter is damaged since the sterility or integrity

of the device may be compromised and thus increasing the risk

of patient infection and device malfunction.

• Use the catheter prior to the

Use By

date specified on the

package.

• Do not attempt to pass the catheter through an introducer

sheath smaller than 10 Fr. Damage to the device may occur.

• Only use guidewires with a diameter ≤ 0.038”.
• To avoid kinking and damaging the catheter, advance slowly

in small increments until the proximal end of the guidewire

emerges from the catheter.

• To avoid damage to the catheter or vessel, do not advance or

withdraw the device without a guidewire in place.

• Catheter should not be advanced into a vessel or stent graft

having a diameter smaller than the catheter outer diameter.

Damage to the device or vessel may occur.

• Carefully monitor the patient’s blood pressure throughout the

procedure.

• If an obstruction in the vessel (e.g., a tortuous bend, stenosis,

calcification, etc.) prevents advancement of the catheter, use

standard techniques to try to dilate and/or straighten the

vessel before continuing to advance the catheter.

• It is recommended that back-up Stent Graft Balloon Catheters

are made available.

• Balloon is highly compliant. Inflate slowly. Do not over-inflate

balloon when modeling graft in vessels. Operator should

visualize the stent graft at all times during balloon inflation

to detect any movement of the stent graft. Use special care in

areas of diseased vessels to avoid rupture or vessel trauma.

• The Stent Graft Balloon Catheter is not intended for use as an

angioplasty or dilatation balloon.

• The device is not for use in endovascular prostheses

contraindicated for use with compliant balloon catheters.

• When aligning the position of the catheter so that the balloon

is in proper position for expansion within vessel or stent graft,

pay careful attention to the fluoroscope location in order to

avoid parallax or other sources of visualization error.

• Do not use the Stent Graft Balloon Catheter for more than 20

inflation/deflation cycles.

• Do not exceed 50 mm balloon diameter and do not exceed 60

cc inflation volume at 50 mm balloon diameter. Adhere to the

balloon inflation guidelines outlined in Table 1.

• The Stent Graft Balloon Catheter has been tested to temporarily

occlude vessels up to 41 mm in diameter.

6. POTENTIAL COMPLICATIONS/ADVERSE EFFECTS

Complications may occur with the use of any stent graft balloon

catheter or during any catheterization procedure. Therefore, only

physicians trained in vascular surgery, interventional radiology or

cardiology, and who have completed training or have experience

with access/support catheters and associated devices should

consider using this device. Possible complications associated with

this type of procedure include but are not limited to the following:

CLINICALLY RELATED:

• Vessel perforation, dissection, rupture or injury
• Occlusion at some locations may cause arrhythmia
• Paresthesia

•  Drug reactions
•  Entry site infection
•  Entry site hematoma
•  Cardiac events
•  Respiratory failure
•  General malaise
•  Arterial thrombosis and/or embolism
• Hemorrhage
• Stroke
•  Aneurysm rupture
•  Renal complications
• Death

DEVICE RELATED:

•  Balloon catching inside of graft during catheter movement
•  Stent graft migration caused by device
•  Balloon rupture
•  Inability to inflate/deflate balloon
•  Inability to insert guidewire
•  Inability to withdraw catheter from introducer

7. PACKAGING, STERILIZATION AND STORAGE

The device has been sterilized using ethylene oxide (EO) and is

supplied sterile and non-pyrogenic. The package label indicates

the

Use By

date.

Do not use the device after the

Use By

date. The device sterility

and integrity may be compromised and possibly result in patient

infection and device malfunction.
The device should be stored in cool dry place.

8. RECOMMENDED ITEMS

Each Stent Graft Balloon Catheter package includes the following:

• Single-use sterile disposable catheter with extension tube and

stopcock mounted on a paperboard card.

Materials required but not provided are:

•  Introducer Sheaths (10 Fr Minimum size)
•  Guidewires (0.038” Maximum diameter)
•  60 cc syringes
• Diluted contrast solution (75% sodium chloride / 25%

renographin) is recommended for balloon inflation/deflation

• Additional Stent Graft Balloon Catheters

It is also recommended that a freely-angled C-Arm with high

resolution fluoroscopy, high quality angiography and Digital

Subtraction Angiography (DSA) be used during the procedure.

9. DEVICE PREPARATION

9.1

Carefully inspect the package and catheter prior to use to

verify no damage occurred during shipment. Do not use

catheter if either the catheter or packaging is damaged or

compromised.

9.2